Biorep Technologies, Inc.
Contract development and manufacturing organization focused exclusively on regulated medical devices. Offers end-to-end services from concept and rapid prototyping through process development, cleanroom assembly, validated sterilization and packaging, and scaled production under ISO 13485 and FDA 21 CFR Part 820 systems. Services emphasize design controls, risk management, supplier quality, and regulatory readiness for global markets.
Industries
N/A
Nr. of Employees
small (1-50)
Biorep Technologies, Inc.
Patents
Products
Surgical instruments and minimally invasive tools (development projects)
Design and production examples include extracorporeal knot delivery instruments, atrial wall retraction systems, suture organization devices, and aortic/mitral retraction cuffs developed for limited-access cardiac procedures.
Islet isolation and diabetes research instrumentation
Development and manufacture of lab instruments for islet isolation, perifusion systems, and islet counting equipment used in diabetes research and cell-therapy workflows.
Pre-validated cleaning, sterilization, and packaging libraries
Packaged validation solutions that provide validated cleaning protocols, sterilization parameter sets, and modular sterile pouches to reduce the scope of customer-specific validation work.
Surgical instruments and minimally invasive tools (development projects)
Design and production examples include extracorporeal knot delivery instruments, atrial wall retraction systems, suture organization devices, and aortic/mitral retraction cuffs developed for limited-access cardiac procedures.
Islet isolation and diabetes research instrumentation
Development and manufacture of lab instruments for islet isolation, perifusion systems, and islet counting equipment used in diabetes research and cell-therapy workflows.
Pre-validated cleaning, sterilization, and packaging libraries
Packaged validation solutions that provide validated cleaning protocols, sterilization parameter sets, and modular sterile pouches to reduce the scope of customer-specific validation work.
Services
Rapid additive and CNC prototyping, design iteration, prototype validation and documentation to support DHF preparation and transition to production.
Full-scale manufacturing services including process development, process validation, equipment qualification, CAPA/change control, and traceability under ISO 13485/FDA QSR.
Cleanroom assembly, multi-component and electromechanical integration, in-process inspection, functional/environmental testing, and sterile packaging interface.
Package design, seal integrity and accelerated aging testing, distribution simulation, and documentation aligned with ISO 11607.
Sterilization process selection, bioburden testing coordination, sterilization validation studies and ongoing monitoring for EtO, gamma, or steam sterilization.
Supplier qualification, quality agreements, risk-based supplier controls, incoming inspection plans, and supplier performance monitoring within an ISO 13485 QMS.
Rapid additive and CNC prototyping, design iteration, prototype validation and documentation to support DHF preparation and transition to production.
Full-scale manufacturing services including process development, process validation, equipment qualification, CAPA/change control, and traceability under ISO 13485/FDA QSR.
Cleanroom assembly, multi-component and electromechanical integration, in-process inspection, functional/environmental testing, and sterile packaging interface.
Package design, seal integrity and accelerated aging testing, distribution simulation, and documentation aligned with ISO 11607.
Sterilization process selection, bioburden testing coordination, sterilization validation studies and ongoing monitoring for EtO, gamma, or steam sterilization.
Supplier qualification, quality agreements, risk-based supplier controls, incoming inspection plans, and supplier performance monitoring within an ISO 13485 QMS.
Expertise Areas
- Medical device design and development
- Contract development and manufacturing (CDMO) for medical devices
- Rapid prototyping and product validation
- Cleanroom assembly and sterile-device manufacturing
Key Technologies
- Additive manufacturing / 3D printing
- CNC machining
- Injection molding (prototyping to production)
- Multi-axis motion systems
News & Updates
Discussion of supplier classification, qualification, incoming inspection, quality agreements, and ongoing supplier performance monitoring under an ISO 13485 QMS.
Explains cleaning, sterilization, and packaging validations and how pre-validated solutions can reduce time and cost for device developers.
Overview of a five-phase design and development process aligned with ISO 13485 and 21 CFR 820 covering concept, design planning, product design, verification/validation, and design transfer.
Commissioned ISO 7/Class 10,000 cleanroom and began contract manufacturing operations; FDA registration updated to Manufacturer.
Awards including South Florida Manufacturer of the Year (<30 Employees) and GrowFL Top 50 Companies to Watch.
Discussion of supplier classification, qualification, incoming inspection, quality agreements, and ongoing supplier performance monitoring under an ISO 13485 QMS.
Explains cleaning, sterilization, and packaging validations and how pre-validated solutions can reduce time and cost for device developers.
Overview of a five-phase design and development process aligned with ISO 13485 and 21 CFR 820 covering concept, design planning, product design, verification/validation, and design transfer.
Commissioned ISO 7/Class 10,000 cleanroom and began contract manufacturing operations; FDA registration updated to Manufacturer.
Awards including South Florida Manufacturer of the Year (<30 Employees) and GrowFL Top 50 Companies to Watch.